Vildagliptin on Gastric Accommodation

NCT ID: NCT03500900

Last Updated: 2018-04-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-01

Study Completion Date

2017-01-01

Brief Summary

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Dipeptidyl peptidase-4 (DPP-4) inactivates glucagon-like peptide-1 (GLP-1). Whether DPP-4 inhibition affects GLP-1 metabolism in vivo and/or food intake remains unknown.

The aim of this study is to evaluate the effect of vildagliptin (DPP-4 inhibitor) on gastric accommodation and ad libitum food intake in healthy volunteers (HVs).These effects will be evaluated in two randomized, placebo-controlled, single-blinded trials. Each protocol will include ten volunteers.

Protocol 1: Sixty minutes after treatment a nutrient drink (270 kcal) will be intragastrically infused and intragastric pressure (IGP) will be measured for one hour.

Protocol 2: 60 min after treatment the participants consume one nutrient drink (300 kcal). Thirty minutes hereafter, the participant will eat ad libitum from a free-choice buffet for 30 minutes. Blood will be collected at several time points to measure active GLP-1 plasma levels.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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Vildagliptin

DPP-4 inhibitor, acute administration (50 mg.)

Group Type EXPERIMENTAL

Vildagliptin 50 mg

Intervention Type DRUG

Acute administration of Vildagliptin, 50 mg.

Placebo

Placebo treatment, acute administration

Group Type PLACEBO_COMPARATOR

Placebo Oral Tablet

Intervention Type DRUG

Acute administration of placebo tablet

Interventions

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Vildagliptin 50 mg

Acute administration of Vildagliptin, 50 mg.

Intervention Type DRUG

Placebo Oral Tablet

Acute administration of placebo tablet

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

\- Aged between 18 to 65 years old

Exclusion Criteria

* presence of symptoms or a history of gastrointestinal diseases
* diabetes
* drug allergies
* psychological disorders
* major gastrointestinal surgery
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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Vildagliptin

Identifier Type: -

Identifier Source: org_study_id

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